Advanced pharmacovigilance training workshop v3 1

Organized by

Department of Clinical Pharmacology Seth GS Medical College, Mumbai under aegis of

Pharmacovigilance Program Of India [PvPI] Saturday, 5th May 2018 09.00 a.m. - 05.00 p.m.

Dr. Jivraj Mehta Lecture Theatre [JMLT] Near Dean’s office, Seth GSMC & KEM Hospital, Mumbai https://sites.google.com/view/kempvigworkshop

Brief about Workshop It is our pleasure to invite you to the workshop on Advanced Pharmacovigilance. Speakers for this workshop will be from premier

medical institutes and the pharmaceutical industry who have vast experience in pharmacovigilance. The workshop is the first of its kind and aims to train prospective candidates in necessary skills to enable to join pharmacovigilance industry. Anyone interested to learn in depth about pharmacovigilance activities may apply.

Brief about our ADR monitoring centre (AMC) Seth G S Medical College and KEM Hospital was enrolled as an AMC under PvPI since the very inception of PvPI under the

leadership of Dr. Urmila Thatte, Professor & HoD, Clinical Pharmacology, as coordinator for NCC-PvPI. Our regional AMC was chosen for field visit to re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT) and measuring the maturity of the system. India. Our AMC

gives regular Vigiflow hands-on training for resident doctors, students, Technical associates (TAs)/Patient safety officers from other AMCs. We are devoted to sensitize medical and paramedical staff, lab technicians, biotechnology students, MSc students on how to fill ADR forms completely and improve quality.

Time

9 - 9.15

9.15 – 10.00

10.00 - 10.45

10.45-11.00

11.00 - 11.45 11.45-12.30

12.30 – 13.00

Topic

Speaker

R Chandrasekhar Deputy Drugs Controller CDSCO

Inauguration & Introduction to Workshop

Avinash Supe Dean Seth GS Medical College & KEM Hospital, Mumbai

Careers in Pharmacovigilance

Mangesh Kulkarni Head Drug Safety (PV) Life Sciences and Healthcare, Tata Consultancy Services

What does a drug safety physician do?

Naveen Chhabra Team Manager - Aggregate Safety Reports (Pharmacovigilance) Cognizant

Tea Global regulations in Sanjay N Menon PV Country Patient Safety Head Indian regulations Novartis in PV Lunch

Time

Topic

Speaker

Moin Don President & CEO PVCON Consulting

13.00 14.00

Role of Artificial Intelligence/ Softwares in case management/ PV ARGUS/ORACLE & Others

14.00 14.30

Pharmacovigilance of Vaccines

Chetanraj Bhamare Safety Physician Serum Institute of India Ltd

PvPI- Current Status

V Kalaiselvan Principal Scientific Officer Indian Pharmacopoeia Commission

14.30 15.00 15.00 15.15

15.15 16.00

16.00 16.45

16.45 –

Naveen Chhabra Team Manager - Aggregate Safety Reports (Pharmacovigilance) Cognizant

Tea Risk Benefit Analysis in Pharmacovigilance PV audits and Inspections

Mufassil Dingankar Pharmacovigilance Specialist PVCON Consulting Moin Don President & CEO PVCON Consulting

Valedictory Function

Topics to be covered:

Drug Safety Department

Drug Safety Physician Functions

Regulatory Compliance

Reports

• • • • •

Data Entry, Case Generation Units Case Processing, Reports, and Transmission Quality Medical Review Functions Quantity-Statistical Review Functions Pharmacovigilance, SOP, REMS: Action Units

• Education of healthcare practitioners • Evaluation of causality for Adverse Drug Reactions • Coding of Adverse Events as per MedDRA • Grading and Analysis of Human System involvement • Narrative writing for outcome of the Adverse Events

• • • • •

WHO and ICH (CIOMS/FDA/EU initiatives) Good Pharmacovigilance Practices- Global Perspective Global Regulatory Compliance ICH-CDISC-Compliant Data Submission FDA-Audit/inspection/Approval/withdrawals

• • • • •

ICSR (Individual Case Safety Reports) ISSR (Integrated Summary of Safety Reports) Expedited and SUSAR reports Aggregate reports PBRER (Periodic Benefit Risk Evaluation Reports)

Topics to be covered:

Signal Detection

Informatics in PVig

Risk benefit analysis methods

• • • • • •

JMP Signal identification Signal analysis and management Data visualization Signal analytics with advanced statistical formulae Regulatory compliance

• Emerging Computer based tools for Pharmacovigilance • Drug safety Technology Vendors • ARIS GLOBAL Total Safety Suite • Various Data Mining tools • Training on the features of Argus Safety • Case processing and discussions on types of cases, case processing in Argus software, quality standards for accurate detection and analysis of drug safety signals.

• (Trade off metric Indices – INHB, BRR, UT-NNT, GBR, Principal of Threes, TURBO, Beckmann) • SRP / Things taken into account while issuing safety alert or label warning – IC values and interpretation

TRAVEL DIRECTIONS Seth G.S. Medical College and KEM hospital is located in Parel, Central Mumbai. It is very well connected by all transport routes. Taxi should be preferred over Mumbai Local trains for non-Mumbai resident delegates.

Place

Distance

Approximate time by taxi

Mumbai Airport

15 kms

45 mins - 1hr

Chhatrapati Shivaji Maharaj Terminus (CSMT)

7.3 kms

20-30 mins

Dadar Terminus

3 kms

10 mins

Lokamanya Tilak Terminus, Kurla

11 kms

30-40 mins

Mumbai Central Railway Station

5.2 kms

20-30 mins

CONTACT INFORMATION Tushar Nishandar & Ketan Asawale Workshop Coordinators Department of Clinical Pharmacology 1st Floor, New OPD Multi-storey Building, Seth G.S Medical College and KEM Hospital Acharya Donde Marg Parel, Mumbai -12 E-mail-kempvigworkshop2018@gmail.com Mobile - 9822379696 (Tushar) /9764593322 (Ketan)

https://sites.google.com/view/kempvigworkshop

REGISTRATION DETAILS • Participant can register by filling following google form. (www.bit.ly/2JBnszu) • It is advised to pay registration fee and be ready with screenshot of payment confirmation webpage/photo of payment receipt before filling up google form.

• Registration fees for all delegates:: Date

Fees (₹)

On or before 28th April, 2018

1549/-

29th April – till Spot registration

1999/-

• Payment should be made only by NEFT. • NEFT details are as follows Seth GS Medical College and KEM Hospital Department Development Fund

Payee Name Account Number

20070291247

IFSC code

MAHB0000079 400014011 Bank of Maharashtra, Vikas Apartments no 64, Dr. Ambedkar Marg, Parel, Mumbai-400012

MICR Code Bank Name and Address

• TWO (2) MMC (Maharashtra Medical Council) credit points will be awarded to attendees from medical background subject to approval from MMC. • Registration acknowledgement and other correspondence will be by e-mail only.